Lumason® Infusion vs. Bolus Administrations
ConditionHeart Diseases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBracco Diagnostics, Inc
About this trial
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Eligibility criteria
Qualifiers
Are at least 18-years old;
Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
Provide their written informed consent and are willing to comply with protocol requirements.
Disqualifiers
Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);
Patient has uncontrolled angina (i.e., uncontrolled on medication);
Patient had a recent myocardial infarction (within the last 3 days and not stabilized);
Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
Trial design
Treatments tested in this trial
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Lumason
Treatment groups
106 Participants
are divided into 2 treatment groupsLocations
6Interventional Cardiology Medical Group91307, West HillsCalifornia, United States
Piedmont Heart Institute30309, AtlantaGeorgia, United States
Beth Israel Deaconess Medical Center02215, BostonMassachusetts, United States
Oregon Health and Sciences University97239, PortlandOregon, United States
Sponsors and collaborators
Bracco Diagnostics, Inc
Lead sponsor
Source ClinicalTrials.gov